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临床试验/NCT02329678
NCT02329678已完成不适用

Efficacy of Guided Tissue Regeneration Membrane in the Healing of Apicomarginal Defects - A Prospective, Controlled Clinical Trial.

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 23 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
主要终点
Clinical attachment level

研究概览

简要总结

Introduction: The present clinical trial was conducted to evaluate the efficacy of membrane barrier in the healing of apicomarginal defects.

Methods: Thirty patients meeting inclusion criteria were selected and allocated randomly into two groups: collagen membrane group and control group. Clinical and radiographic measurements were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after surgery. The criteria for success included the absence of clinical signs and symptoms, and complete or incomplete radiographic healing.

详细描述

Title: Efficacy of guided tissue regeneration membrane in the healing of apicomarginal defects - A prospective, controlled clinical trial.

Apicomarginal defects, localized bony defects characterised by total deficiency of alveolar bone over the entire root length, have been reported to have lower success rate ranging from 27-37% (1-2). It is proposed that formation of long junctional epithelium during healing phase over the dehisced root surface may contribute to relatively lower success rate of such lesions (1, 3-4).

Successful treatment may, thus, depend not only on elimination of bacteria from the root canal system but also on preventing epithelial proliferation along denuded root surface. GTRtechniques with barrier membranes have been proposed as important adjunct in the management of endodontic-periodontal lesions. Such a membrane, when placed over a bony defect, may prevent the downgrowth of epithelial cells and provide an opportunity for the cells of the periodontal ligament and endosteum to regenerate the lost tissue (5-6).

Literature is replete with case reports and clinical studies (7-18) which demonstrate high success with GTR membrane, and advocate its use in apicomarginal defects (19-20). However, caution must be exercised in drawing any clinically relevant conclusions as none of these clinical studies had a control group. To the best of the investigator knowledge, only three experimental studies (21-23) have evaluated the utility of guided tissue regeneration in apicomarginal defects. While two of these have advocated use of the membrane in such lesions, one could not find any significant benefit of GTR.

Kim et al (24), in a recent prospective clinical study, reported 73.7% healing success by using calcium sulphate and collatape (resorbable collagen membrane) in periapical lesion with complete denudement of buccal bone plate (type F) and 63.6% success even if no membrane is used in E type of lesions. Recently, Song et al (25) also reported 70.4% healing success in apicomarginal defects without use of any GTR technique.These data suggest that there is possibility of healing of apicomarginal defects without use of any GTR technique, by using modern microsurgical techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 47 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility criteria included apicomarginal communication confined to buccal aspect with a pocket depth (PD) of >6 mm and recurrent episodes of purulent discharge, teeth with negative response to vitality tests, with radiographic evidence of periapical radiolucencies, failed previous root canal treatment or retreatment at least 1 year previously, and adequate final restoration with no clinical evidence of coronal leakage

排除标准

  • Teeth with vertical root fracture, resorptive processes extending to more than the apical third of the root, and subjects with chronic generalized periodontitis, systemic disease contraindicating surgical procedures, and conditions affecting rate of healing like diabetes and smoking were excluded from the study.

结局指标

主要结局

Clinical attachment level

时间窗: baseline to one year

Pocket depth

时间窗: baseline to one year

Gingival margin position

时间窗: baseline to one year

size of apical radiolucency

时间窗: baseline to one year

次要结局

  • pain swelling sinus tract(base line to one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjay Tewari

Professor

Postgraduate Institute of Dental Sciences Rohtak

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